Trials / Active Not Recruiting
Active Not RecruitingNCT05036252
Study of Cardiopulmonary Exercise Testing in Women Who Have HER2-Positive Breast Cancer With Mild Cardiotoxicity
A Pilot Study of Cardiopulmonary Exercise Testing in Patients With Left Ventricular Systolic Dysfunction Receiving HER2-Targeted Therapy
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 23 (actual)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to find out how much oxygen is used during a cardiopulmonary exercise test (CPET) in women who have mild cardiotoxicity after standard treatment for HER2-positive breast cancer, and to see whether the results of this test can be used to predict how well participants' heart and lungs will work if they continue to receive this kind of treatment.
Conditions
- Breast Cancer
- HER2-positive Breast Cancer
- HER2-positive Metastatic Breast Cancer
- Breast Cancer Stage I
- Breast Cancer Stage II
- Breast Cancer Stage III
- Breast Cancer Stage IV
- Cardiotoxicity
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Cardiopulmonary Exercise Test | All enrolled participants will undergo a cardiopulmonary exercise test (CPET). The CPET will be conducted using an electronic motorized treadmill with 12-lead ECG monitoring performed by ACSM-certified exercise physiologists. |
| DIAGNOSTIC_TEST | Echocardiogram | Resting assessment of LVEF and GLS will be evaluated through Conventional 2D and Doppler echocardiograms will be performed per protocol using a commercially available ultrasound scanner, according to the American Society of Echocardiography (ASE) recommendations for a comprehensive examination. |
| DIAGNOSTIC_TEST | Echocardiography | As soon as possible following completion of the CPET, subjects will be placed in the supine position and 2D echocardiographic images will be obtained in the apical 4-/ 3-/2-chamber views. |
Timeline
- Start date
- 2021-08-27
- Primary completion
- 2026-08-27
- Completion
- 2026-08-27
- First posted
- 2021-09-05
- Last updated
- 2025-09-30
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05036252. Inclusion in this directory is not an endorsement.